- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07659327
Effects Of Sahrmann's Versus McGill Exercise In Patients With Non-Specific Low Back Pain
Effects Of Sahrmann's Versus McGill Exercise On Pain, Disability, And Range Of Motion In Patients With Non-Specific Low Back Pain
The goal of this clinical trial is to learn whether Sahrmann exercises or McGill exercises are more effective for reducing pain and improving function in adults with non-specific low back pain. It will also evaluate which exercise program is more effective in improving spinal range of motion.
The main questions it aims to answer are:
Do Sahrmann exercises reduce pain more effectively than McGill exercises? Do Sahrmann exercises improve disability more effectively than McGill exercises? Do Sahrmann exercises improve lumbar range of motion more effectively than McGill exercises?
Researchers will compare a Sahrmann exercise program with a McGill exercise program to determine which approach produces better outcomes in patients with non-specific low back pain.
Participants will:
Be randomly assigned to either a Sahrmann exercise group or a McGill exercise group.
Receive standard physical therapy treatment, including heat therapy and transcutaneous electrical nerve stimulation (TENS).
Perform the assigned exercise program under the supervision of a physiotherapist.
Attend exercise sessions 3-5 times per week during the study period. Complete assessments of pain, disability, and lumbar range of motion before and after the intervention.
Have pain measured using the Numeric Pain Rating Scale (NPRS), disability measured using the Oswestry Disability Index (ODI), and lumbar range of motion measured using a Baseline Bubble Inclinometer.
연구 개요
상세 설명
Non-specific low back pain (NSLBP) is one of the most prevalent musculoskeletal disorders and a major cause of disability worldwide. It is characterized by pain localized between the lower rib margins and the gluteal folds without a specific identifiable pathology. Individuals with NSLBP often experience pain, reduced spinal mobility, impaired motor control, and functional limitations that negatively affect daily activities and quality of life.
Exercise-based rehabilitation is widely recommended as a first-line treatment for NSLBP. Core stabilization exercises have gained considerable attention because deficits in trunk muscle function and lumbopelvic stability are believed to contribute to the persistence and recurrence of low back pain. Among the commonly used approaches, Sahrmann exercises and McGill exercises are designed to improve spinal stability through different mechanisms.
The Sahrmann approach emphasizes motor control training and the correction of movement impairments through progressive lumbopelvic stabilization exercises. The McGill approach focuses on enhancing spinal stability and muscular endurance while minimizing spinal loading through a series of stabilization exercises commonly referred to as the McGill Big Three. Although both approaches are frequently used in rehabilitation practice, evidence directly comparing their effectiveness in individuals with NSLBP remains limited.
This randomized controlled trial aims to compare the effects of Sahrmann exercises and McGill exercises on clinical outcomes in adults with non-specific low back pain. Participants will be randomly allocated to one of two treatment groups and will receive a supervised exercise program in addition to standard physical therapy care. Clinical assessments will be conducted before and after the intervention period to evaluate changes in pain, functional disability, and lumbar mobility.
The findings of this study may help identify the more effective exercise-based rehabilitation approach for individuals with non-specific low back pain and provide evidence to support clinical decision-making in physical therapy practice.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sumrod Akram
- 전화번호: 03324806143
- 이메일: samrood.akram@riphah.edu.pk
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosed patients of non-specific low back pain Adults between 18-35 years. Both male and female included Low back pain for minimum of three months NPRS score 3-7 will be recruited in this study.
Exclusion Criteria:
History of any trauma and spinal injury History of previous lumbar surgery History of cancer, spinal infection, rheumatologic diseases, spine fracture, red flag signs.
Congenital anomly (scoliosis, kyphosis) Systemic diseases affecting bones & joints such as rheumatoid arthritis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group A: (Sahrmann's Exercises)
The patients in this group will receive conventional Sahrmann's exercises along with baseline treatment for non-specific low back pain.
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Group A will receive sahrmann's exercises after the baseline treatment. It will be including 5 levels: Level 1 The participant slowly raised one leg to a position of approximately 90° hip flexion with 90° knee flexion. Level 2 From the final position of the previous level, the participant slowly lowered one leg such that the heel contacted the ground/plinth. Level 3 From the end position of level 1, the participant slowly lowered one leg such that the heel reached approximate 12cm above the ground. Then the leg slid out to fully extend the knee. Level 4 From the final position of level 1, the participant slowly lowered both legs together such that the heels contacted the plinth. Then the legs slid out to fully extend the knees. Level 5 From the final position of level 1, the participant slowly lowered both legs simultaneously such that the heels reached 12 cm above the ground. The legs then slid out to fully extend the knees. |
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활성 비교기: Group B: (McGill Exercises)
The patients in this group will receive McGill Exercises along with baseline treatment for non-specific low back pain.
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Patients will receive three exercises for rehabilitating lower back pain, termed the McGill Big Three (MGB3). Mcgill begins with motion exercise (cat-camel motion exercise. It consists of six to eight cycle of spinal flexion and extension in quadruped position.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numerical Pain Rating Scale (NPRS)
기간: upto 6 weeks
|
In the current study, patients with NPRS score 3-7 will be recruited.
Patient level of pain will be assessed using this scale.
NRS is 11-points (NRS-11) which counts the pain and is wildly used in clinical settings because it is easy to administer and score.
The patient is asked to indicate the value of his pain on the scale.
A 11-point scale was used, with "0" representing "no pain" and "10" representing the "most severe pain imaginable" at the time of assessment (10).
The Numeric Pain Rating Scale (NPRS) demonstrates moderate to excellent test-retest reliability with ICC values ranging from 0.58 to 0.93, and good construct validity with correlation coefficients of 0.48 to 0.54
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upto 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oswestry Disability Index (ODI)
기간: upto 6 weeks
|
The ODI was the primary outcomes used to assess self-reports of disability caused by LBP.
The ODI is made up of 10 sections scored from 0 to 5 points, each section contain 6 statements with the total score ranging from 0 to 50 points.
A higher score on questionnaires indicates a higher level of disability.
The ODI (ICC > 0.84) has been recognized as valid and reliable tools for patients suffering from chronic LBP.
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upto 6 weeks
|
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Baseline Bubble Inclinometer
기간: upto 6 weeks
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A Baseline Bubble Inclinometer (Model 10602 built by Fabrication Enterprise Inc., USA) was used to measure the active back flexion and extension range of motion without thoraco-lumbar pain.
To evaluate the active thoraco-lumbar flexion and extension range of motion, the inclinometer was used at the T12-L1 spinous process.
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upto 6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Fatima Khan, MSPT*, Riphah International University
간행물 및 유용한 링크
일반 간행물
- Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
- Ghorbanpour A, Azghani MR, Taghipour M, Salahzadeh Z, Ghaderi F, Oskouei AE. Effects of McGill stabilization exercises and conventional physiotherapy on pain, functional disability and active back range of motion in patients with chronic non-specific low back pain. J Phys Ther Sci. 2018 Apr;30(4):481-485. doi: 10.1589/jpts.30.481. Epub 2018 Apr 13.
- Bielewicz J, Daniluk B, Kamieniak P. VAS and NRS, Same or Different? Are Visual Analog Scale Values and Numerical Rating Scale Equally Viable Tools for Assessing Patients after Microdiscectomy? Pain Res Manag. 2022 Mar 29;2022:5337483. doi: 10.1155/2022/5337483. eCollection 2022.
- Ahmad SNS, Letafatkar A, Brewer BW, Sharifnezhad A. Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients: a randomized controlled trial. BMC Musculoskelet Disord. 2023 Aug 29;24(1):684. doi: 10.1186/s12891-023-06815-x.
- Hernandez-Lucas P, Leiros-Rodriguez R, Mota J, Garcia-Soidan JL. Effects of a back school-based intervention on non-specific low back pain in adults: a randomized controlled trial. BMC Complement Med Ther. 2023 Jul 10;23(1):229. doi: 10.1186/s12906-023-04061-1.
- Niroomand T, Rabiei M, Mohammadi BJJoAST. Investigating the Effects Janda's and Sahrmann's Correcting Exercise Approaches on Trunk Muscles Function in Young Girls with Lower Crossed Syndrome. 2023;7(3):48-58.
- Alkhathami K, Alshehre Y, Brizzolara K, Weber M, Wang-Price S. Effectiveness of Spinal Stabilization Exercises on Movement Performance in Adults with Chronic Low Back Pain. Int J Sports Phys Ther. 2023 Feb 1;18(1):169-172. doi: 10.26603/001c.68024. eCollection 2023.
- Chan EWM, Hamid MSA, Nadzalan AM, Hafiz E. Abdominal muscle activation: An EMG study of the Sahrmann five-level core stability test. Hong Kong Physiother J. 2020 Dec;40(2):89-97. doi: 10.1142/S1013702520500080. Epub 2020 Mar 10.
- Alonso-Sal A, Alonso-Perez JL, Sosa-Reina MD, Garcia-Noblejas-Fernandez JA, Balani-Balani VG, Rossettini G, Villafane JH. Effectiveness of Physical Activity in the Management of Nonspecific Low Back Pain: A Systematic Review. Medicina (Kaunas). 2024 Dec 16;60(12):2065. doi: 10.3390/medicina60122065.
- Morotani M. General principles of the Movement System Impairment diagnostic system. The Journal of Manual Physical Therapy. 2022;22(1):29-35.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- REC/RCR & AHS/25/0137
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Sahrmann's Exercises에 대한 임상 시험
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Istanbul University - Cerrahpasa아직 모집하지 않음허약한 노인 | 노쇠 증후군 | 노인병 | 프리프레일 노인